Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ROADRUNNER NIMBLE FLOPPY HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INC ROADRUNNER NIMBLE FLOPPY HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER Back to Search Results
Catalog Number RFPC-35-260
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/08/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product code: dqx.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
The complainant reported that the roadrunner nimble floppy hydrophilic wire guide was binding to the catheter during use which resulted in a loss of the hydrophilic coating.The product problem did not result in any reported serious injuries to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ROADRUNNER NIMBLE FLOPPY HYDROPHILIC WIRE GUIDE
Common Device Name
DQX WIRE, GUIDE, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7899511
Report Number1820334-2018-02906
Device Sequence Number13873921
Product Code DQX
UDI-Device Identifier00827002090293
UDI-Public(01)00827002090293(17)180825(10)6119595
Combination Product (Y/N)N
Initial Reporter CountryZA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,other,use
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/25/2018
Device Catalogue NumberRFPC-35-260
Device Lot Number6119595
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2018
Initial Report FDA Received Date09/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-